UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029830 |
|---|---|
| Receipt number | R000034072 |
| Scientific Title | The clinical effect of new-prescribed LGA-supplement for facial skin of middle-aged and elderly women. |
| Date of disclosure of the study information | 2017/11/06 |
| Last modified on | 2018/08/24 13:01:42 |
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Basic information
Public title
The clinical effect of new-prescribed LGA-supplement for facial skin of middle-aged and elderly women.
Acronym
Clinical effect of new-prescribed LGA-supplement for ladies.
Scientific Title
The clinical effect of new-prescribed LGA-supplement for facial skin of middle-aged and elderly women.
Scientific Title:Acronym
Clinical effect of new-prescribed LGA-supplement for ladies.
Region
| Japan |
Condition
Condition
Aging change in face skin, such as the wrinkles of the eye-corners, the climacteric symptom and/or the weary symptom.
Classification by specialty
| Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to demonstrate the clinical effect for the wrinkles of eye-corners, the climacteric and tired symptoms of elderly women after aging by treatment of a newly prescribed LGA supplement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes in the wrinkles of eye-corners after 2 months-treatment of the LGA supplement.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Newly compounded LGA supplement, for 2 months.
Interventions/Control_2
Placebo of the newly compounded LGA supplement, for 2 months.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1. The woman with the deep wrinkles, i.e., more than 4 during 8 stages of wrinkles scale.
2. The woman demonstrated more than 40 score in weary awareness score and the climacteric questionnaire, respectively.
3. The woman who isn't taking other supplements currently.
4. The woman who demonstrates written informed consent.
Key exclusion criteria
1. The person who can't participate entirely this clinical trial for 2 months.
2. The person who is not the suitable participant for this trial by the chief study director.
3. Pregnant woman and lactating woman
4. The person who received an other supplement, experimental drug or clinical trial medicine within for 3 months of starting
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rie Yamashita M.D.,Ph.D |
Organization
Shonan Kamakura General Hospital
Division name
Plastic and Aesthetic Surgery Dept.
Zip code
Address
1370-1, Okamoto, Kamakura, Kanagawa, 247-8533, JAPAN
TEL
0467-46-1717
s_yamada@shonankamakura.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shizuhiro Yamada DVM, PhD |
Organization
Shonan Kamakura General Hospital
Division name
Center for Clinical and Translational Science
Zip code
Address
1370-1, Okamoto, Kamakura, Kanagawa, 247-8533, JAPAN
TEL
0467-46-1717
Homepage URL
s_yamada@shonankamakura.or.jp
Sponsor or person
Institute
Plastic and Aesthetic Surgery Dept.
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
TOKIWA Pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
湘南鎌倉総合病院（神奈川県鎌倉市）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 05 | Day |
Last modified on
| 2018 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034072
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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